Poor outcomes with cryoplasty for lower extremity arterial occlusive disease

ObjectivesCryoplasty has been proposed as a different therapy to address the problems of recurrent lesions. We reviewed our experience with cryoplasty to determine its outcome treating patients with lesions in native vessels and within stents.MethodsA retrospective review of all patients undergoing cryotherapy between 2004 and 2008 was conducted. Patency was defined by at least one of the following criteria: flow through the vessel demonstrated by angiography or duplex ultrasonography, maintenance of an ankle-brachial index (ABI) greater than 0.10 above the preprocedural value, or maintenance of a palpable pedal pulse that was absent before the procedure in an asymptomatic patient. Patency, limb salvage, symptomatic improvement, and freedom from surgical bypass were determined with Kaplan-Meier survival analysis and compared by log-rank testing. Multivariate analysis was performed by Cox proportional-hazards regression.ResultsEighty-eight cryoplasty procedures were performed in 71 patients, with 35 procedures for in-stent restenosis and 37 for native vessel disease. Sixteen of 88 procedures in grafts were excluded from analysis secondary to combined disease process and/or bypass graft stenosis. Lesions treated with cryoplasty had an average of 2.9 prior endovascular interventions. Eighty-five percent of the lesions were described as complex (multifocal, diffuse, or occlusion) and the mean lesion length was 15 ± 10 cm. Initial cryoplasty technical success rate was 68% (25 of 37) for native vessels and 71% (25 of 35) for in-stent procedures. One year primary patency for the native vs stent group was 17% vs 28%, respectively (P = .18). The 1-year primary assisted patency for the native vs stent group was 28% vs 47%, respectively (P = .33). The 1-year secondary patency for the native vs stent group was 41% vs 57% (P = .42), respectively. Freedom from claudication at 1 year for the native vs stent group was 32% vs 21% (P = .80). Compared to balloon angioplasty, cryoplasty has an averaged up-cost of $1851.50 per procedure.ConclusionCryoplasty was used in patients with extensive disease and multiple prior interventions. Cryoplasty provided poor patency rates and poor relief from claudication at 1 year in this population. Overall, cryoplasty seems to be an expensive endovascular tool with marginal clinical improvement in our experience.